510(k) K090885

NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER by Nephros, Inc. — Product Code FIP

K090885 is an FDA 510(k) premarket notification submitted by Nephros, Inc. for the device "NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER". The FDA issued a decision of Substantially Equivalent on June 29, 2009. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Nephros, Inc. has at least 8 other 510(k) clearances on record.